Center for Scientific Review; Notice of Closed Meetings, 12794-12795 [2020-04372]
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12794
Federal Register / Vol. 85, No. 43 / Wednesday, March 4, 2020 / Notices
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product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product, FASENRA
(benralizumab). FASENRA is indicated
for the add-on maintenance treatment of
patients with severe asthma aged 12
years and older and with an
eosinophilic phenotype. Subsequent to
this approval, the USPTO received
patent term restoration applications for
FASENRA (U.S. Patent Nos. 7,179,464;
7,718,175; and 8,101,185) from Kyowa
Hakko Kirin Co., Ltd., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
September 18, 2018, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
FASENRA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
FASENRA is 4,127 days. Of this time,
3,763 days occurred during the testing
phase of the regulatory review period,
while 364 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: July 30, 2006. The
applicant claims July 29, 2006, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 30, 2006,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 16, 2016. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for FASENRA (BLA 761070) was
initially submitted on November 16,
2016.
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3. The date the application was
approved: November 14, 2017. FDA has
verified the applicant’s claim that BLA
761070 was approved on November 14,
2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 5 years, or 1,552
days or 1,244 days of patent term
extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04363 Filed 3–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Hypertension and Microcirculation.
Date: March 23, 2020.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuroimmunology,
Neuroinflammation, Infection, and Brain
Cancer.
Date: March 24, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR19–385:
Environmental Risks for Psychiatric Disorder:
Biological Basis of Pathophysiology.
Date: March 24, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Motivated Behavior, Alcohol and
Heavy Metals.
Date: March 25, 2020.
Time: 1:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
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Federal Register / Vol. 85, No. 43 / Wednesday, March 4, 2020 / Notices
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Michael Selmanoff, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5164,
MSC 7844, Bethesda, MD 20892, (301) 435–
1119, selmanom@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cardiovascular Sciences.
Date: March 25, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Eugene Carstea, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4130,
MSC 7818, Bethesda, MD 20892, (301) 408–
9756, carsteae@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Drug Discovery and
Clinical Field Studies.
Date: March 25, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Tera Bounds, DVM, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892, (301) 435–
2306, boundst@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Leveraging Health Information Technology
(Health IT) to Address Minority Health and
Health Disparities.
Date: March 25, 2020.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, (301) 435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Toxicology
and Digestive, Kidney and Urological
Systems AREA/REAP Review.
Date: March 25, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Aiping Zhao, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188,
MSC 7818, Bethesda, MD 20892–7818, (301)
435–0682, zhaoa2@csr.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cognitive Processing and
Neuropsychiatric Disorders.
Date: March 25, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Jenny Raye Browning,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20892, (301) 402–8197,
jenny.browning@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Clinical Field Studies.
Date: March 25, 2020.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Neerja Kaushik-Basu,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3198,
MSC 7808, Bethesda, MD 20892, (301) 435–
2306, kaushikbasun@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuroscience and Bioengineering.
Date: March 25, 2020.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Robert C Elliott, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3130,
MSC 7850, Bethesda, MD 20892, (301) 435–
3009, elliotro@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 27, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–04372 Filed 3–3–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
PO 00000
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12795
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Preventative
Health Services Use.
Date: March 9, 2020.
Time: 12:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Kimberly Firth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Building, 7201
Wisconsin Avenue, Suite 2W200, Bethesda,
MD 20892, (301) 402–7702, firthkm@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Conference
Grants.
Date: March 13, 2020.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Dario Dieguez, Jr., Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Building, Suite
2W200, 7201 Wisconsin Avenue, Bethesda,
MD 20892, (301) 827–3101, dario.dieguez@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–04377 Filed 3–3–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 85, Number 43 (Wednesday, March 4, 2020)]
[Notices]
[Pages 12794-12795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04372]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Hypertension and Microcirculation.
Date: March 23, 2020.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Larry Pinkus, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4132, MSC 7802, Bethesda, MD 20892, (301) 435-
1214, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neuroimmunology, Neuroinflammation,
Infection, and Brain Cancer.
Date: March 24, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-
1246, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR19-385: Environmental Risks for Psychiatric Disorder:
Biological Basis of Pathophysiology.
Date: March 24, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Julius Cinque, MS, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892, (301) 435-
1252, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Motivated Behavior, Alcohol and Heavy
Metals.
Date: March 25, 2020.
Time: 1:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
[[Page 12795]]
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Michael Selmanoff, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD
20892, (301) 435-1119, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Cardiovascular Sciences.
Date: March 25, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Garden Inn Bethesda, 7301 Waverly Street,
Bethesda, MD 20814.
Contact Person: Eugene Carstea, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4130, MSC 7818, Bethesda, MD
20892, (301) 408-9756, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Drug Discovery and Clinical Field
Studies.
Date: March 25, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD
20892, (301) 435-2306, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Leveraging Health Information Technology (Health
IT) to Address Minority Health and Health Disparities.
Date: March 25, 2020.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, (301) 435-0684, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Toxicology and Digestive, Kidney and Urological Systems AREA/
REAP Review.
Date: March 25, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Aiping Zhao, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 2188, MSC 7818, Bethesda, MD 20892-7818, (301)
435-0682, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Cognitive Processing and Neuropsychiatric
Disorders.
Date: March 25, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Jenny Raye Browning, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, Bethesda, MD 20892, (301) 402-8197, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Topics in Clinical Field Studies.
Date: March 25, 2020.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications and/or
proposals.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD
20892, (301) 435-2306, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neuroscience and Bioengineering.
Date: March 25, 2020.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Robert C Elliott, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3130, MSC 7850, Bethesda, MD
20892, (301) 435-3009, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: February 27, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-04372 Filed 3-3-20; 8:45 am]
BILLING CODE 4140-01-P
